MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE

Model Number	20895-00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, it was reported that the laser pilot light was visible from the base of the depth stop and locking interface prior to inserting the probe into the patient.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
The neuroblate system instructions for use contain laser safety warnings as risk mitigations for this event: section 4.3, general warnings: "laser eye protection provided with the neuroblate system must be worn in the mri scanner room during operation of the laser." section 8.6.2: "warning: the three ldp connector lines must never be bent, kinked or crushed.This also applies to the laser fiber and all other lines within the connector module cable bundle.Damaged lines may result in ldp operation failure or may reduce laser energy delivered to the target tissue.Damaged portions of laser fiber lines may interrupt heating and may result in equipment damage or injury to the user or patient." no harm was observed in this event, and the event description provided by the clinical specialist indicates that the warnings were heeded upon identification of damaged laser delivery probe (ldp) laser line.Therefore, these risk mitigations remain effective.

• Brand Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer (Section G): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: jordon honeck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 15471453
• Report Number: 3009970070-2022-00029
• Device Sequence Number: 11471162
• Product Code: GEX
• UDI-Device Identifier: 00816589021011
• UDI-Public: 00816589021011
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 20895-00
• Device Catalogue Number: FFS002-01
• Device Lot Number: 12143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown